Study of Efficacy and Safety of Vildagliptin as add-on Insulin Therapy in T2DM Patients

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

Japan

Study Type

Interventional

Intervention

Vildagliptin (LAF237)

Placebo

Insulin

Metformin

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus (T2DM) focused on measuring Diabetes Mellitus (DM) ,, diabetes,, noninsulin-dependent diabetes mellitus (NIDDM),, adult-onset diabetes,, high blood sugar,, T2DM

Eligibility Criteria

20 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Confirmed diagnosis of T2DM by standard criteria.
HbA1c ≥ 7.0 to ≤ 10% at Visit 1.
Age: ≥ 20 to < 75 years old at Visit 1.
BMI ≥ 20 to ≤ 35 kg/m2 at Visit 1.

Exclusion Criteria:

FPG ≥ 270 mg/dL (≥15 mmol/L) at Visit 1.
Type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes.
Significant heart diseases
Hepatic disorder

Other protocol defined inclusion/exclusion criteria may apply

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vildagliptin (LAF237)

Placebo

Arm Description

Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study

In this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study

Outcomes

Primary Outcome Measures

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 12 Weeks Between Treatment Groups

HbA1c was performed on a blood sample obtained and measured by high performance liquid chromatography performed at a central laboratory.

Secondary Outcome Measures

Percentage of Patients Meeting Responder Rates in HbA1c

Responder rate was analyzed in categories: Criterion 1- Endpoint HbA1c ≤ 6.5%, Criterion 2- Endpoint HbA1c < 7% , Criterion 3- Endpoint HbA1c < 7% in patients with baseline HbA1c ≤ 8%, Criterion 4- HbA1c reduction from baseline at endpoint ≥ 1%, Criterion 5- HbA1c reduction from baseline at endpoint ≥ 0.5%. The number of patients analyzed for Criterion 1 and 2 include only patients with baseline HbA1c ≥ 7% (> 6.5%) and endpoint HbA1c measurement. The number of patients analyzed for Criterion 3 includes only patients with 7% ≤ baseline HbA1c ≤ 8% and endpoint HbA1c measurement. The number of patients analyzed for Criterion 4 and 5 include patients with both baseline and endpoint HbA1c measurements.

Change From Baseline in Fasting Plasma Glucose (FPG) at 12 Weeks

FPG was performed on a blood sample obtained and analyzed at a central laboratory.

Number of Participants With Incidence of Hypoglycemia and Severe Hypoglycemia

Hypoglycemic events are defined as a) symptoms suggestive of hypoglycemia, where the patient is able to initiate self-treatment and plasma glucose measurement is < 56 mg/dL (grade 1), b) symptoms suggestive of hypoglycemia, where the patient is unable to initiate self-treatment and plasma glucose measurement is < 56 mg/dL (grade 2), c) symptoms suggestive of hypoglycemia, where the patient is unable to initiate self-treatment and no plasma glucose measurement is available (suspected grade 2)

Number of Participants With Adverse Events, Serious Adverse Events and Death

The occurrence of adverse events was sought by non-directive questioning of the patient at each visit. Adverse events are defined as appearance or worsening of any undesirable symptom, vital sign, or medical conditions. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.

Full Information

NCT ID

NCT02002221

First Posted

November 29, 2013

Last Updated

February 2, 2016

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02002221

Brief Title

Study of Efficacy and Safety of Vildagliptin as add-on Insulin Therapy in T2DM Patients

Official Title

A 12-week, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Equa (Vildagliptin) 50 mg Bid as an add-on Therapy to Insulin, With or Without Metformin, in Patients With Type 2 Diabetes Mellitus

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

December 2013 (undefined)

Primary Completion Date

February 2015 (Actual)

Study Completion Date

February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary

The purpose of this study was to assess the efficacy and safety of vildagliptin 50 mg bid add-on therapy to improve overall glycemic control in patients with T2DM inadequately controlled by insulin, with or without concomitant metformin treatment. It was agreed with PMDA to conduct a postmarketing clinical trial to further collect the efficacy and safety data of vildagliptin especially in Japanese patients when it iwas used on top of insulin.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus (T2DM)

Keywords

Diabetes Mellitus (DM) ,, diabetes,, noninsulin-dependent diabetes mellitus (NIDDM),, adult-onset diabetes,, high blood sugar,, T2DM

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

156 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vildagliptin (LAF237)

Arm Type

Experimental

Arm Description

Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

In this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study

Intervention Type

Drug

Intervention Name(s)

Vildagliptin (LAF237)

Other Intervention Name(s)

Vildagliptin

Intervention Description

Corresponds to vildagliptin (LAF237) 50 mg tablets twice daily

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching placebo of vildagliptin 50 mg twice daily

Intervention Type

Drug

Intervention Name(s)

Insulin

Intervention Description

Patients continued their prescribed insulin dose. The dose of insulin remained within a 10% increase of the baseline dose throughout the trial (with no change in frequency or insulin type) unless dose adjustments were required for safety reasons. The insulin dose was allowed to be decreased for safety reasons at anytime without specific dose limits at the Investigator's discretion.

Intervention Type

Drug

Intervention Name(s)

Metformin

Intervention Description

Patients continued their prescribed metformin dose, if applicable.

Primary Outcome Measure Information:

Title

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 12 Weeks Between Treatment Groups

Description

HbA1c was performed on a blood sample obtained and measured by high performance liquid chromatography performed at a central laboratory.

Time Frame

Baseline, week 12

Secondary Outcome Measure Information:

Title

Percentage of Patients Meeting Responder Rates in HbA1c

Description

Responder rate was analyzed in categories: Criterion 1- Endpoint HbA1c ≤ 6.5%, Criterion 2- Endpoint HbA1c < 7% , Criterion 3- Endpoint HbA1c < 7% in patients with baseline HbA1c ≤ 8%, Criterion 4- HbA1c reduction from baseline at endpoint ≥ 1%, Criterion 5- HbA1c reduction from baseline at endpoint ≥ 0.5%. The number of patients analyzed for Criterion 1 and 2 include only patients with baseline HbA1c ≥ 7% (> 6.5%) and endpoint HbA1c measurement. The number of patients analyzed for Criterion 3 includes only patients with 7% ≤ baseline HbA1c ≤ 8% and endpoint HbA1c measurement. The number of patients analyzed for Criterion 4 and 5 include patients with both baseline and endpoint HbA1c measurements.

Time Frame

Baseline, week 12

Title

Change From Baseline in Fasting Plasma Glucose (FPG) at 12 Weeks

Description

FPG was performed on a blood sample obtained and analyzed at a central laboratory.

Time Frame

Baseline, week 12

Title

Number of Participants With Incidence of Hypoglycemia and Severe Hypoglycemia

Description

Hypoglycemic events are defined as a) symptoms suggestive of hypoglycemia, where the patient is able to initiate self-treatment and plasma glucose measurement is < 56 mg/dL (grade 1), b) symptoms suggestive of hypoglycemia, where the patient is unable to initiate self-treatment and plasma glucose measurement is < 56 mg/dL (grade 2), c) symptoms suggestive of hypoglycemia, where the patient is unable to initiate self-treatment and no plasma glucose measurement is available (suspected grade 2)

Time Frame

12 weeks

Title

Number of Participants With Adverse Events, Serious Adverse Events and Death

Description

The occurrence of adverse events was sought by non-directive questioning of the patient at each visit. Adverse events are defined as appearance or worsening of any undesirable symptom, vital sign, or medical conditions. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

74 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Confirmed diagnosis of T2DM by standard criteria. HbA1c ≥ 7.0 to ≤ 10% at Visit 1. Age: ≥ 20 to < 75 years old at Visit 1. BMI ≥ 20 to ≤ 35 kg/m2 at Visit 1. Exclusion Criteria: FPG ≥ 270 mg/dL (≥15 mmol/L) at Visit 1. Type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes. Significant heart diseases Hepatic disorder Other protocol defined inclusion/exclusion criteria may apply

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Fukuoka-city

State/Province

Fukuoka

ZIP/Postal Code

810-8798

Country

Japan

Facility Name

Novartis Investigative Site

City

Fukuoka-city

State/Province

Fukuoka

ZIP/Postal Code

815-0071

Country

Japan

Facility Name

Novartis Investigative Site

City

Fukutsu-city

State/Province

Fukuoka

ZIP/Postal Code

811-3217

Country

Japan

Facility Name

Novartis Investigative Site

City

Kitakyushu-city

State/Province

Fukuoka

ZIP/Postal Code

800-0295

Country

Japan

Facility Name

Novartis Investigative Site

City

Koriyama-city

State/Province

Fukushima

ZIP/Postal Code

963-8851

Country

Japan

Facility Name

Novartis Investigative Site

City

Mito-city

State/Province

Ibaraki

ZIP/Postal Code

311-4153

Country

Japan

Facility Name

Novartis Investigative Site

City

Ibusuki-city

State/Province

Kagoshima

ZIP/Postal Code

891-0401

Country

Japan

Facility Name

Novartis Investigative Site

City

Yokohama-city

State/Province

Kanagawa

ZIP/Postal Code

221-0802

Country

Japan

Facility Name

Novartis Investigative Site

City

Kumamoto-city

State/Province

Kumamoto

ZIP/Postal Code

861-8039

Country

Japan

Facility Name

Novartis Investigative Site

City

Kumamoto-city

State/Province

Kumamoto

ZIP/Postal Code

861-8520

Country

Japan

Facility Name

Novartis Investigative Site

City

Yatsushiro-city

State/Province

Kumamoto

ZIP/Postal Code

866-8533

Country

Japan

Facility Name

Novartis Investigative Site

City

Kyoto-city

State/Province

Kyoto

ZIP/Postal Code

615-0035

Country

Japan

Facility Name

Novartis Investigative Site

City

Sendai-city

State/Province

Miyagi

ZIP/Postal Code

980-0021

Country

Japan

Facility Name

Novartis Investigative Site

City

Hirakata-City

State/Province

Osaka

ZIP/Postal Code

573-0153

Country

Japan

Facility Name

Novartis Investigative Site

City

Izumisano-city

State/Province

Osaka

ZIP/Postal Code

598-8577

Country

Japan

Facility Name

Novartis Investigative Site

City

Osaka-city

State/Province

Osaka

ZIP/Postal Code

530-0001

Country

Japan

Facility Name

Novartis Investigative Site

City

Osaka-city

State/Province

Osaka

ZIP/Postal Code

534-0021

Country

Japan

Facility Name

Novartis Investigative Site

City

Takatsuki-city

State/Province

Osaka

ZIP/Postal Code

569-1096

Country

Japan

Facility Name

Novartis Investigative Site

City

Ageo-city

State/Province

Saitama

ZIP/Postal Code

362-8588

Country

Japan

Facility Name

Novartis Investigative Site

City

Saitama-city

State/Province

Saitama

ZIP/Postal Code

336-0963

Country

Japan

Facility Name

Novartis Investigative Site

City

Sayama-city

State/Province

Saitama

ZIP/Postal Code

350-1305

Country

Japan

Facility Name

Novartis Investigative Site

City

Tokorozawa-city

State/Province

Saitama

ZIP/Postal Code

359-1161

Country

Japan

Facility Name

Novartis Investigative Site

City

Adachi-ku

State/Province

Tokyo

ZIP/Postal Code

123-0845

Country

Japan

Facility Name

Novartis Investigative Site

City

Chiyoda-ku

State/Province

Tokyo

ZIP/Postal Code

101-0024

Country

Japan

Facility Name

Novartis Investigative Site

City

Chuo-ku

State/Province

Tokyo

ZIP/Postal Code

103-0027

Country

Japan

Facility Name

Novartis Investigative Site

City

Chuo-ku

State/Province

Tokyo

ZIP/Postal Code

103-0028

Country

Japan

Facility Name

Novartis Investigative Site

City

Chuo-ku

State/Province

Tokyo

ZIP/Postal Code

104-0061

Country

Japan

Facility Name

Novartis Investigative Site

City

Nerima-ku

State/Province

Tokyo

ZIP/Postal Code

177-0041

Country

Japan

Facility Name

Novartis Investigative Site

City

Nerima-ku

State/Province

Tokyo

ZIP/Postal Code

177-0051

Country

Japan

Facility Name

Novartis Investigative Site

City

Ota-ku

State/Province

Tokyo

ZIP/Postal Code

144-0051

Country

Japan

Facility Name

Novartis Investigative Site

City

Suginami-ku

State/Province

Tokyo

ZIP/Postal Code

166-0004

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

26620049

Citation

Hirose T, Suzuki M, Tsumiyama I. Efficacy and Safety of Vildagliptin as an Add-on to Insulin with or without Metformin in Japanese Patients with Type 2 Diabetes Mellitus: A 12-week, Double-Blind, Randomized Study. Diabetes Ther. 2015 Dec;6(4):559-571. doi: 10.1007/s13300-015-0147-6. Epub 2015 Nov 30.

Results Reference

derived

Type 2 Diabetes Mellitus (T2DM)

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial